Being open policy (incorporating the duty of candour)

Contents

1 Introduction

Being open refers to the processes for communicating adverse events with patients, families, and carers. It is the opportunity to say sorry at the onset.

Duty of candour refers to the ‘volunteering of all relevant information to persons who have or may have been harmed by the provision of services, whether or not the information has been requested and whether or not a complaint or a report about that provision has been made’.

The principles of being open and the duty of candour provide a structure and process for communicating with people in the right way when an incident has occurred. The Care Quality Commission (CQC) also set out expected standards required by healthcare providers in Regulation 20 ‘Duty of Candour’ (Health and Social Care Act 2008 (Regulated Activities) Regulations, 2014).

Hard Truths (DH, 2014) acknowledges that the professional values of individual clinicians are critical in ensuring an open culture. This means that along with incidents being reported, we should act in an open and transparent way when an incident has occurred.

All Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) staff should be aware of their professional and statutory roles and responsibilities when an incident occurs, and this means being open and honest with the relevant people.

The trust recognises that a culture of openness and honesty creates a positive learning environment where teams and individuals can be involved in improving care and sharing those improvements. Transparency is key in producing an open-minded safety culture.

1.1 The 10 principles of being open and actions

When something goes wrong, openness and honesty is welcomed by patients and being open is the right thing to do. Being open is a process rather than a one-off event and is underpinned by 10 principles. The process should be applied in all patient safety incidents and the details of this can be found in appendix A the 10 principles of being open, for information and guidance and appendix B for the NHS resolution, ‘saying sorry’ leaflet 2017.

1.2 Duty of candour, an introduction

When an incident is more serious, it is more important that the being open principles are followed, and the actions completed. It is a statutory duty for all NHS bodies to be open, honest, and candid when a patient is harmed. There is an offence of giving false or misleading information. The duty is overseen by The Care Quality Commission (CQC).

RDaSH has integrated the process for capturing, recording and managing the duty of candour within the on incident reporting form (Ulysses IR1).

The criteria that must be met to fulfil the duty are listed in appendix C, duty of candour criteria and requirements

1.3 The relevant person

The regulation defines the relevant person as the patient, the patient may also request that that a suitable person acts on their behalf making them both relevant people. This person may or may not be a relative but will be a person the patient has trust in and who they have agreed to be involved in their care.

In certain situations such as when a patient dies or is incapacitated, this extends to people acting lawfully on their behalf.

2 Purpose

The purpose of this policy is to set out the arrangements and legal requirements for open and honest communication following an incident, complaint or claim in compliance with the being open principles and duty of candour requirements.

Good communication is a vital component of dealing with incidents and errors and it is a legal and professional duty of all health care professionals to communicate openly and honestly with a patient’s family and, or carer(s) when something goes wrong with care and treatment.

3 Scope

This policy applies to all clinical staff and staff who have a key role in sharing information with the relevant people following an incident.

Incidents which come under the serious incident criteria are investigated under the incident management policy and are therefore not specifically covered by this policy.

4 Responsibilities, accountabilities and duties

4.1 The trust

Having policies and procedures in place to support best practice, effective management, service delivery, management of associated risks and meet national and local legislation and, or requirements.

Ensuring that there are systems in place that do not obstruct anyone from exercising the duty.

4.2 Executive director, with lead responsibility

The executive director of nursing and allied health professionals is the lead executive director for this policy. They are responsible for the effective management of clinical risk, by liaising with the care group directors who are responsible for the effective management of clinical risk within the trust’s clinical services.

This will include responsibility for ensuring being open principles and duty of candour are appropriately applied to the investigation and management of incidents, complaints, and claims.

They will also ensure that there are appropriate systems in place to share learning.

4.3 Care group directors, nurse directors, service managers and modern matrons

All care group directors, care group nurse directors, deputy care group directors, heads of corporate service and matrons are responsible for the dissemination and implementation of this policy within their departments.

They are also responsible for creating an environment within their services where open, timely and clear communication and information sharing is encouraged in line with the being open principles and duty of candour requirements. This includes ensuring staff are aware of the system for reporting incidents and ensuring that appropriate staff are trained in the principles and procedure relating to being open and the duty of candour.

4.4 Head of patient safety (patient safety specialist)

The head of patient safety is responsible for providing support to directors, care group nurse directors, deputy care group directors, head of corporate services and matrons to facilitate the effective implementation and monitoring of this policy.

They will ensure that the principles of being open, and requirements of the duty of candour are discussed and embedded as part of the learning process for incidents.

Any breaches in the duty will be reported to care group directors and the clinical commissioning groups.

4.5 Duty of candour lead

When an incident has been identified, a nominated person takes responsibility for employing the principles of the duty of candour. This person is usually the manager of the team involved in the incident but will be decided by the modern matron or deputy care group directors, heads of corporate services. This person will remain involved throughout the process and ensure findings are fed back to the relevant people.

4.6 Lead investigator

Any member of staff nominated to investigate an incident should comply with this policy and where appropriate, involve the patient and, or their carers and other relevant teams and organisations (for example where patient care extends beyond RDaSH) investigation. For further information see the RDaSH incident management policy.

The lead investigator should maintain contact with the duty of candour lead throughout the investigation. The team manager or service manager has a key role in ensuring the findings are shared.

4.7 Medical devices and projects officer (MDPO)

The MDPO is responsible for the day-to-day monitoring of the duty of candour process and will monitor the Ulysses IR1 system for incidents which trigger the duty of candour. They will produce reports and provide staff with advice about the process. See appendix J for further information.

4.8 All staff

All staff should comply with the principles of being open and the requirements of the duty of candour with patients and, or their carers as outlined in this policy.

Staff should report all incidents promptly and clearly to ensure that the appropriate actions can be taken to ensure an open and honest culture.

5 Procedure or implementation

5.1 Reporting the incident

The required process is outlined in the flow chart at appendix D duty of candour step by step and appendix E.

When any incident occurs, the members of staff involved are to complete an incident report using the Ulysses IR1 system. This report identifies whether the incident is a patient safety incident, and the level or harm that occurred as a result of the event.

In some cases, the incident may not initially involve RDaSH staff or the incident may be reported to staff by someone else; such as a patient, visitor or other organisation. These are also to be reported on the Ulysses IR1 system, including in the report all information that is available.

5.2 Being open actions

The actions required to comply with the being open process can be found in appendix A, the 10 principles of being open.

Also see the flow chart at appendix D duty of candour step by step and appendix E which outline the process to be followed.

5.3 Notifiable patient safety incident

The definition of a ‘notifiable safety incident’ which will trigger the duty of candour, is any unintended or unexpected incident in the provision of a regulated activity which, in the reasonable opinion of a healthcare professional, could result in, or appears to have resulted in, moderate or severe harm or death or “prolonged psychological harm”. The definitions of “moderate” and “severe” harm are consistent with those used within the NHS for reporting under the national reporting and learning system and the existing contractual duty under the NHS standard contract. Near misses are not notifiable safety incidents.

• Minor treatment is defined as first aid, additional therapy, or additional medication. It does not include any extra stay in hospital or any extra time as an outpatient, or continued treatment over and above the treatment already planned; nor does it include a return to surgery or readmission.
• Moderate increase in treatment is defined as a return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another area such as intensive care as a result of the incident.
• Permanent harm directly related to the incident and not related to the natural course of the patient’s illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ, or brain damage.
• The death must be related to the incident rather than to the natural course of the patient’s illness or underlying condition.

Also see actual harm grading scale at appendix F.

RDaSH as integrated the process of capturing, recording and managing the duty of candour into its Ulysses risk management system. All staff responsible for the duty of candour, or incident investigation, should be aware of how to undertake the duty of candour process using the system.

Within the ULYSSES IR1 form is a record of the perceived actual impact (harm) caused. If this is recorded as moderate harm or above, then the incident has triggered the duty of candour.

In many cases, the presence of psychological harm caused by the incident will not be recognised until after the 28-day period. In these cases, a new incident report is required documenting the presence of psychological harm from the original incident.

5.4 Duty of candour actions

All patient safety incidents require the being open actions to be carried out. If, however, the incident is of such a severity that the duty of candour applies, then further actions are required. These further actions follow on from the being open actions and are:

5.4.1 As soon as possible after the incident

• Offer and provide support to the relevant people after the incident, throughout the investigation and ongoing as required.
• The duty of candour lead is to meet the relevant person, in person (if possible), and inform them that the incident has occurred, apologise, inform them what happened as far as we are aware and what actions are to be taken next.
• The date and details of this contact are recorded on the Ulysses IR1 in the duty of candour ‘relevant person contacted’ section by the duty of candour lead.
• If contact is not possible, for example, there is no relevant person or the person is clinically unwell, this is entered onto the Ulysses IR1.

5.4.2 First letter within 10 working days of the incident

Share with the patient and, or relevant person, in writing, the original notification and the results of any further enquiries.

This should include:

• all the information given verbally during the face-to-face meeting
• an apology
• any further information that has come to light since the meeting
• an outline of the investigation that is in progress
• any relevant support details

The duty of candour letter template available at appendix G reflects a scenario and can be adapted to meet individual needs. These templates are guides only and the letter should be personal and relevant to the case.

The date the letter was sent or given to the relevant person should be recorded on the Ulysses IR1 in the duty of candour ‘Written Explanation’ section by the duty of candour lead. If contact is not possible, for example, there is no relevant person or the person is clinically unwell, this is entered onto the Ulysses IR1.

On rare occasions, it may not be possible for the letter to be sent within 10 working days. In these instances, an explanation must be given for reporting purposes and a record of the reason should be made. This will be reported to the care group directors and the clinical commissioning group by the head of patient safety.

5.4.3 Investigation and feedback within 60 working days of the incident

Feedback should be facilitated by the duty of candour lead with the lead investigator as they will have had the most recent contact with the relevant people.

• Written feedback should be offered to the relevant person. The final investigation report should be concise, in an appropriate format to meet the requirements of the relevant person and should be restricted to the incident.
• The findings from the structured review or a root cause analysis for pressure ulcers should be fed back in letter format. This is the responsibility of the duty of candour lead. A template for this is available in appendix H.
• If the incident has undergone a full serious incident (SI) investigation, the feedback may be provided as either a full copy of the SI report or a redacted version if necessary. A covering letter template is available in appendix I.
• The final duty of candour report should be concise, easy to understand by the relevant person and restricted to the incident. It may be suitable to share the full serious incident report, although in some cases a shorter report may be preferable
• This can be a distressing time for patients, families and carers especially where a death has occurred. It is acknowledged that those involved may not wish to receive a report in any format. Where this is the case, a record of the conversation should be made and the Ulysses IR1 should be updated to acknowledge this.
• The date actions were taken, notifications given, letters sent and outcomes are to be recorded with the initial incident on the Ulysses IR1 form by the duty of candour lead or the lead investigator.

The timescales for each investigation will follow the standard requirements as identified in the incident management policy unless agreement to extend the timeframe has been accepted by all concerned.

See the flow chart at appendices D and E.

5.5 Specific guidance

5.5.1 Provide an explanation

In keeping with the principles of being open, for non-notifiable incidents the member of staff involved should provide the patient or significant other with a full explanation of what is known at the time, including what further action is to be taken. This can be given by another member of staff if it is decided that this would be more beneficial. Staff should speak to their manager for advice about how to approach this if they are unsure.

The relevant person should be kept abreast of what will happen and should be given the opportunity to be involved as much as they wish.

5.5.2 Information to be shared

Communication should be timely, informing the patient and, or their carer what has happened as soon as is practicable.

A step-by-step account of all relevant facts known about the incident at the time should be given, in person, by one or more appropriate representatives of the trust. This should:

• include as much or as little relevant information as the relevant person or people want to hear
• be jargon-free and explain any complicated terms in line with the accessible information standards
• include an explanation of any further planned enquiries and investigations
• be given in a manner that relevant person or people can understand, for example, staff should consider if appropriate interpreters, advocates, communication aids and so on, should be present, but should be conscious of any potential breaches of confidentiality in doing so

5.5.3 Investigation of the incident

All incidents should be investigated by an appropriate manager. The level and depth of the investigation will be in line with the seriousness of the incident and where a serious incident investigation is required, the incident will be investigated by the lead investigator from the Patient Safety and Investigations team (see incident management policy).

This appropriate manager becomes the duty of candour lead.

In many cases the investigation will be immediate and short with the apology, explanation and results of the investigation being delivered all at the same time.

In other cases these may be three distinct stages, the apology, the explanation, and the results of the investigation.

The process for investigating the incident should be explained to the patient and, or their carer informing them that they will be kept up to date as any new information emerges as a result of any investigation.

The Investigator for the incident is responsible for liaising with and providing information in a timely, truthful and open manner to the patient and, or carer in line with the agreed investigation process.

5.5.4 De-logging serious incidents

An incident that requires investigation is logged on the Ulysses IR1 system. There will be occasions where the incident and report will be de-logged, for example when a structured review or root cause analysis investigation finds that the trust caused no harm to the patient. Where the duty of candour process has begun, it should always be followed through with the relevant people and letter outlining the findings should be provided.

5.5.5 Provision of additional support as required

Patients and or their carers should also be provided with support in a timely manner to meet their needs. This may involve an independent advocate or an interpreter. Information on the patient advisory and liaison service (PALS) and other relevant support groups should be given as soon as possible. The offer of additional support and the outcome should be recorded. It should be borne in mind that the need for support may change throughout the investigation process.

There should also be recognition of the traumatic effect that adverse outcomes and their aftermath might have on NHS staff as well as patients and their relatives.

5.5.6 Patients who do not agree with the information provided

Sometimes, despite the best efforts of staff, the relationship between the patient, their family and carers and the healthcare professional breaks down.

They may not accept the information provided, may desire a higher level of investigation, or may not wish to participate in the process. In this case, the following strategies may assist:

• where the patient consents, ensure their family and carers are involved in discussions from the beginning
• write a comprehensive list of the points that the patient, their family, and carers disagree with and reassure them you will follow up these issues
• offer the patient, their family and carers another contact person with whom they may feel more comfortable, this could be another member of the team or a manager from another team or service
• use a mutually acceptable mediator to help identify the issues between the healthcare organisation and the patient, and to look for a mutually agreeable solution
• ensure the patient, their family and carers are fully aware of the formal complaints’ procedure

5.7 Special considerations

The being open approach may need to be modified according to the individual patient or personal circumstances, for example (but not restricted to):

• when a patient dies
• patients who have a cognitive impairment and may lack capacity
• patients with a different language or cultural considerations
• patients with different communication needs
• children and young people
• when there is a corresponding criminal enquiry

5.7.1 When a patient dies

When an incident has resulted in a patient death it is crucial that communication is sensitive, empathetic, and open. A verbal apology will be given as soon as possible after the patient’s death. It is particularly important to consider the emotional state of bereaved relatives or carers and to involve them in deciding when it is appropriate to discuss what has happened.

A written notification and apology from the duty of candour lead should follow (see letter template, appendix G)

Usually, the being open discussion and any investigation will occur before the coroner’s inquest. In some circumstances the trust may consider it more appropriate to wait for the coroner’s inquest before holding the being open discussion with the family and or carers. It is important to explain that they will be kept informed as information is released from the coroner’s office.

In most instances where someone dies it can be unclear if the services provided by the trust were at fault and whether duty of candour should be applied. See below for further detail:

• if death is reported to be due to natural causes, duty of candour is not applicable
• the main provider of care is not the trust, duty of candour is not applicable.

Where a suicide or child death has taken place, these incidents will always trigger the duty of candour. Where the child death is due to natural causes, duty of candour does not apply.

N.B. In all cases, duty of candour is only applicable if the death occurs while the patient is receiving regulated care (NHS funded care) or within 6 months of them being discharged from care.

5.7.2 Where there is no identified relevant person

Where no contact details have been recorded or updated in the clinical record and, or the relevant person cannot be easily identified, staff should ask the coroner, general practitioner or other official body if they can provide contact details. This can then be recorded on the Ulysses IR1 as ‘other relevant person not identified’ but it should later be recorded on the Ulysses IR1 if contact is made. A clear record should be made of the attempts to contact the relevant person along with any reasons why contact has not been made.

Where staff are unclear, they should seek advice from management.

5.7.3 Patients who have a cognitive impairment and may lack capacity

Wherever possible the patient will be involved in communications about what has happened. An advocate with appropriate skills should be available to the person to assist in the communication process.

Some patients may have authorised a person to act on their behalf by an attorney appointed under a registered lasting power of attorney for health and welfare, but they can only act when the person has been assessed to lack capacity to make the specific decision. In these cases steps must be taken to clarify the extent of this authority and the being open discussion would be held with the holder of the power of attorney. This person would be the relevant person with regard to the duty of candour requirements. Where there is no such person, staff may act in the patient’s best interest when they have been assessed as lacking capacity in deciding who the appropriate person is to discuss information with, regarding the welfare of the patient as a whole and not simply their medical interests.

See Mental Capacity Act 2005 policy.

The need for translation and advocacy services, and consideration of special cultural needs (such as for patients from cultures that make it difficult for a woman to talk to a male about intimate issues), must be considered when planning to discuss incident information.

It would be worthwhile to obtain advice from an advocate or translator before the meeting on the most sensitive way to discuss the information. Avoid using ‘unofficial translators’ and or the patient’s and, or carers as they may distort information by editing what is communicated. Refer to the interpreters policy (provision, access and use of, for patients, service users and carers).

5.7.3 Patients with different communication needs

Some patients will have particular communication difficulties, such as a hearing impairment. Plans for the meeting should fully consider these needs. Knowing how to enable or enhance communications with a patient is essential to facilitating a process, focusing on the needs of individuals and their families and being personally thoughtful and respectful.

5.7.4 Patients with different communication needs

Some patients will have particular communication difficulties, such as a hearing impairment. Plans for the meeting should fully consider these needs. Knowing how to enable or enhance communications with a patient is essential to facilitating a process, focusing on the needs of individuals and their families and being personally thoughtful and respectful.

5.7.5 Children and young people

The trust’s Safeguarding Children team can provide advice related to assessing and managing risks in relation to children and young people and child protection, including information-sharing with other agencies See also trust safeguarding children policy and multiagency safeguarding children procedures.

The legal age of maturity for giving consent to treatment is 16. It is the age at which a young person acquires the full rights to make decisions about their own treatment and their right to confidentiality becomes vested in them rather than their parents or guardians. However, it is still considered good practice to encourage competent children and young people to involve their families in decision making.

The courts have stated that younger children who understand fully what is involved in the proposed procedure can also give consent (known as Gillick competence). Where a child is judged to have the cognitive ability and the emotional maturity to understand the information provided, he or she should be involved directly in the being open process after an incident. The opportunity for parents to be involved should still be provided unless the child expresses a wish for them not to be present.

Where children and young people are deemed not to have sufficient maturity or ability to understand, consideration needs to be given to whether information is provided to the parents alone or in the presence of the child. In these instances the parents’ views on the issue should be sought.

5.8 Documenting all communication

A clear and contemporaneous record must be maintained of all communication. It is important throughout the being open process that records of discussions with the patient and, or their carers as well as the incident investigation are maintained.

The initial apology and explanation given should be documented in the Ulysses IR1 form, and in-depth detail recorded in the patient’s record.

The Ulysses IR1 form will be the main record repository for duty of candour processes, with copies of letters and written notes being scanned and uploaded into the system.

Once the relevant person has been informed in person about the notifiable or patient safety incident, the trust must provide the relevant person with a written note of the discussion, and copies of all correspondence must be kept by the trust, along with any enquiries or investigations, and the outcome or results of those enquiries or investigations. A record of such communications should also be included in the patient record, Ulysses IR1 and complaints and Serious Incidents files where applicable.

Any routine day to day ‘being open’ communication such as an incident outside the duty of candour and the remit of the above policies will be recorded in the patient’s health record.

Staff should make every reasonable effort to contact the relevant people through various communication means. All attempts to contact the relevant people should be documented. If the relevant person declines to contact the trust, their wishes should be respected and a record of this kept.

Good documentation is crucial. Discussions around the time of an incident should be recorded in the patient records. Any subsequent meetings should be have minutes taken and followed up by letter.

The outcomes or results of any enquiries and investigations should also be provided in writing to the relevant people, should they wish to receive them. Any correspondence from relevant person(s) relating to the incident should be responded to in an appropriate and timely manner and a record of communications kept.

5.9 Next steps

The relevant person should be advised on what further enquires are appropriate and they should be given all reasonable opportunities to be involved as much as they wish to be in the progress of any enquiries.

New information may emerge during the course of any inquiries into the incident, and the relevant people must be informed of new information as it arises. The trust must keep the relevant people informed about the conclusions of our enquiries, and provide them with a single point of contact for any questions and further opportunities to discuss the case:

• on an on-going basis throughout the course of their continuing recovery and, or treatment, and during any investigation or inquiry
• at times and amounts of their choosing until they are satisfied that all relevant information has been disclosed

5.10 Continuity of care

Patients are entitled to expect they will continue to receive all usual treatment and continue to be treated with respect and compassion. If a patient expresses a preference for their healthcare needs to be taken over by another team, the appropriate arrangements should be made for them to receive the treatment elsewhere.

Patient or service users, their families and carers should be reassured that they will continue to be treated according to their clinical needs even in circumstances where there is a dispute between them and the team. They should also be informed that they have the right to continue their treatment elsewhere if they have lost confidence in the team involved in the incident.

When a patient or service user has been harmed during the course of treatment and requires further therapeutic management or rehabilitation, they should be informed, in an accessible way, of the ongoing clinical management plan.

5.11 Practical support

In line with the expectations of all staff regardless of any incident, patients will be provided with all reasonably practical and emotional support necessary to help overcome the physical, psychological and emotional impact of the incident. At a direct level this will include:

• treating all patients and their families with respect, consideration and empathy
• offering the option of immediate emotional support during the notifications, for example from a family member, a care professional or a trained advocate
• offering access to help with understanding what is being said, for example, via interpretative services, non-verbal communication aids, written information, Braille
• in line with the accessible information standards

In addition, staff will be supported by relevant process and individuals within the trust to:

• offer access to any necessary remedial treatment to minimise the harm caused
• provide information about available impartial advocacy and support services, local health watch and other relevant support groups, such as cruse bereavement care and action against medical accidents (AvMA), to help them deal with the outcome of the incident
• arrange for care and treatment to be delivered by another professional or team or provider as far as reasonably practical, should the relevant people wish.

5.12 Support for staff

During the course of their duties, RDaSH staff may find themselves involved in an incident. This can be distressing, and staff may require support. This should be provided via the team manager who will identify the relevant level of support and assist the staff member to access this in a timely manner. This could be via occupational health, or informal arrangements within the trust.

6 Training implications

Whilst there are no mandatory training needs in relation to this policy, the CQC set out expected standards required by healthcare providers in Regulation 20 ‘Duty of Candour’ (Health and Social Care Act 2008 (Regulated Activities) Regulations, 2014). Training is required for:

• lead investigators who will have contact with patients, their families and carers during the course of their investigation
• any other individual or group with a responsibility for implementing the contents of this policy
• all clinical staff who during the course of their work will have direct contact with patients their carers

Training sessions will be delivered through the learning and development department to raise awareness of the duty of candour for managers, including how to record duty of candour compliance on the Ulysses IR1 system.

As a trust policy, all staff need to be aware of the key points that the policy covers. Staff can be made aware through a variety of means such as:

• one to one or supervision
• team brief
• weekly newsletter
• team meetings
• trust wide email notices
• group supervision

7 Monitoring arrangements

7.1 Number of duty of candour incidents

• How: Safeguard output report.
• Who by: MDSO.
• Reported to: Trust dashboard for reporting at appropriate meetings.
• Frequency: Monthly.

7.2 Open duty of candour incidents

• How: E-mail feedback.
• Who by: MDSO.
• Reported to: Care group directors.
• Frequency: Monthly.

8 Equality impact assessment screening

Download the equality impact assessment for this policy.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individual’s capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act (2005).

9 Links to any other associated documents

• Listening and responding to concerns and complaints policy (formally complaints handling policy)
• Freedom to speak up policy: raising concerns (whistleblowing) policy
• Healthcare record keeping policy
• Healthy workplaces staff support and stress at work policy
• Incident management policy
• Interpreters policy (provision, access and use of, for patients, service users and carers)
• MCA Mental Capacity Act 2005 policy
• Patient advice and liaison service (PALS) policy
• Safe and secure handling of medicines manual

10 References

• Hard Truths (2014) Department of Health.
• NHS Resolution (NPSA) (2017) Saying sorry when things go wrong: Being Open.
• The 10 Principles Of ‘Being Open’ Adapted From National Patient Safety Agency NPSA (2009).
• NPSA (2009) Being Open: Communicating Patient Safety Incidents with patients their families and carers following a patient safety incident.
• Report of the Mid Staffordshire NHS Foundation Trust Public Enquiry (2013).
• CQC guidance Regulation 5 and regulation 20, November 2014.

11 Appendices

11.1 Appendix A 10 Principles of being open

11.1.1 Acknowledgement

All patient safety incidents should be acknowledged and reported as soon as they are identified. Notify and apologies to the patient or relevant person, verbally or face to face where possible unless the person cannot be contacted or declines notification. In cases where the patient, their family and carers inform healthcare staff when something untoward has happened, it must be taken seriously from the outset. Any concerns should be treated with compassion and understanding by all healthcare professionals.

11.1.2 Truthfulness, timeliness and clarity of communication

Information about a patient safety incident must be given to patients, their families, and carers in a truthful and open manner by an appropriately nominated, person. Patients should be provided with a step-by-step explanation of what happened, that considers their individual needs and is delivered openly. Communication should also be timely; patients, their families and carers should be provided with information about what happened as soon as practicable. It is also essential that any information given is based solely on the facts known at the time. Healthcare professionals should explain that new information may emerge as an incident investigation is undertaken, and that patients, their families and carers will be kept up to date with the progress of an investigation. Patients, their families, and carers should receive clear, unambiguous information and be given a single point of contact for any questions or requests they may have. They should not receive conflicting information from different members of staff, and the use of medical jargon, which they may not understand, should be acknowledged.

11.1.3 Apology

Patients, their families, and carers should receive a meaningful apology, one that is a sincere with expression of sorrow or regret for the harm that has resulted from a patient safety incident. This should be in the form of an appropriately worded and agreed manner of apology as early as possible. Where the death or injury of a person has occurred, an apology does not constitute an admission of liability or unsatisfactory professional performance.

A decision should be made as to who is the most appropriate member of staff to give both verbal and written apologies to patients, their families, and carers. The decision should consider seniority, relationship to the patient, and experience and expertise in the type of patient safety incident that has occurred. Verbal apologies are essential because they allow face-to-face contact between the patient, their family and carers and the healthcare team. This should be given as soon as staff are aware an incident has occurred. A written apology, which clearly states the healthcare organisation is sorry for the suffering and distress resulting from the incident, must also be given. It is important not to delay giving a meaningful apology for any reason,

including: setting up a more formal multidisciplinary Being open discussion with the patient, their family and carers if required; fear and apprehension; or lack of staff availability. Delays are likely to increase the patient’s, their families and their carers’ sense of anxiety, anger or frustration.

11.1.4 Recognising patients, families, and carers expectations

Patients, their families and carers can reasonably expect to be fully informed of the issues surrounding a patient safety incident, and its consequences, in a face-to-face meeting with representatives from the healthcare organisation. They should be treated sympathetically, with respect and consideration. They should also be provided with support if they require it, in a manner appropriate to their needs.

When communicating with relatives and when appropriate, the issue of consent should also be considered and any discussion in relation to the patient wishes should be clearly documented.

11.1.5 Professional support

All staff, whether directly employed or independent contractors, should report patient safety incidents and staff should feel supported throughout the incident. They should not be unfairly exposed to punitive disciplinary action, increased medico-legal risk, or any threat to their registration.

The Just Culture Guide (NHS Improvement, 2018) supports a conversation between managers about whether a staff member involved in a patient safety incident requires specific individual support or intervention to work safely.

11.1.6 Risk Management and systems improvement

The trust investigation process will be used to identify any causes of a patient safety incident.

11.1.7 Multidisciplinary responsibility

Most healthcare provision is through multidisciplinary teams. This should be reflected in the way that patients, their families, and other relevant people are communicated with when things go wrong. This will ensure that the being open process is consistent with the philosophy that incidents usually result from systems failures and rarely from the actions of an individual.

11.1.8 Clinical governance

Being open requires the support of patient safety and quality improvement processes through clinical governance frameworks in which patient safety incidents are investigated and analysed to find out what can be done to prevent their recurrence. These findings should be disseminated to healthcare professionals so that they can learn from patient safety incidents.

Within the trust, monitoring and reporting is carried out through the Ulysses system.

11.1.9 Confidentiality

Being open should give full consideration of, and respect for, the patient’s, their families and other relevant people’s and staff privacy and confidentiality. Details of a patient safety incident should at all times be considered confidential. The consent of the individual concerned should be sought prior to disclosing information beyond the clinicians involved in treating the patient, in line with the CQC’s guidance for outcome 20. Where this is not practical, or an individual refuses to consent to the disclosure, it may still be lawful if justified in the public interest, or where those investigating the incident have statutory powers for obtaining information.

Communications with parties outside of the clinical team should also be on a strictly need to know basis and, where practicable, records should be anonymous. In addition, it is good practice to inform the patient, their family and carers about who will be involved in the investigation before it takes place and give them the opportunity to raise any objections.

11.1.10 Continuity of care

Patients are entitled to expect that they will continue to receive all usual treatment and continue to be treated with dignity, respect and compassion. If a patient expresses a preference for their healthcare needs to be taken over by another team or person, the appropriate arrangements should be made for them to do so.

Please note, the being open approach may need to be modified according to the individual patient or personal circumstances, for example (but not restricted to):

• when a patient dies
• when there is no identified ‘relevant person’
• patients in the community
• patients who have a cognitive impairment and may lack capacity
• patients with a different language or cultural considerations
• patients with different communication needs
• children and young people
• when there is a corresponding criminal enquiry (see section 5.7 special considerations)

11.2 Appendix B NHS resolution saying sorry leaflet

Saying sorry meaningfully when things go wrong is vital for everyone involved in an incident, including the patient, their family, carers, and the staff that care for them.

Saying sorry is:

• always the right thing to do not an admission of liability acknowledges that something could have gone better the first step to learning from what happened and preventing it recurring

11.2.1 Why?

Not only is it a moral and right thing to do, it is also a statutory, regulatory, and professional requirement. It can also support learning and improve patient safety.

11.2.2 When?

As soon as possible after you become aware something has gone wrong you should seek out the patient and or their family and say sorry and acknowledge what has happened and tell them that you will find out more. Reassure them that you will keep them informed.

11.2.3 Who?

Everyone can say sorry, but you may need to be supported to do so. You may need the backing of more senior people and staff may need training but it should not stop you from simply saying sorry. As part of an initial apology it is best practice to provide the patient and their family with a key contact wherever possible.

11.2.4 What if there is a formal complaint or claim?

The Compensation Act 2006 states; ‘an apology, an offer of treatment or other redress, shall not of itself amount to an admission of negligence or breach of statutory duty. (source: Compensation Act 2006, chapter 29, page 3).

In fact, delayed or poor communication makes it more likely that the patient will seek information in a different way such as complaining or taking legal action. The existence of a formal complaint or claim should never prevent or delay you saying sorry.

11.2.5 How?

The way you say sorry is just as important as saying it. An apology should demonstrate sincere regret that something has gone wrong and this includes recognised complications referred to in the consent process. It should be confidential and tailored to the individual patient’s needs.

Where possible you should say sorry in person and involve the right members of the healthcare team. It should be heartfelt, sincere, explain what you know so far and what you will do to find out more.

It is the starting point of a longer conversation; as over time this will lead to sharing information about what went wrong, what you will do differently in the future. It is vital to avoid acronyms and jargon in all communications.

You may also need to say sorry in writing where significant harm has been caused or in response to a written complaint. An example of this could be:

• “I wish to assure you that I am deeply sorry for the poor care you have been given and that we are all truly committed to learning from what happened. I apologise unreservedly for the distress this has caused you and your family”

11.2.6 What about the duty of these steps include candour?

The statutory duty of candour requires all NHS staff to act in an open and transparent way. Regulations governing the duty set out the specific steps healthcare professionals must follow if there has been an unintended or unexpected event which has caused moderate or severe harm to the patient.

These steps include informing people about the incident, providing reasonable support, truthful information and an apology. Saying sorry forms an integral part of this process. Process should never stand in the way of providing a full explanation when something goes wrong.

Don’t say:

• I’m sorry you feel like that
• we’re sorry if you’re offended
• I’m sorry you took it that way
• we’re sorry, but…

Do say:

• I’m sorry ‘X’ happened
• we’re truly sorry for the distress caused
• I’m sorry, we have learned that…

“We have never, and will never, refuse cover on a claim because an apology has been given.” Helen Vernon, Chief Executive, NHS Resolution.

For more information:

• Nursing and Midwifery Council and General Medical Council joint guidance on openness and honesty when things go wrong (opens in new window)
• Reports and consultations on complaint handling (parliamentary and health service ombudsman) (opens in new window)
• AvMA (Action against Medical Accidents) Duty of Candour leaflet (opens in new window)
• Care Quality Commission, Regulation 20: Duty of Candour (opens in new window)

11.2.7 The NHS Constitution

Patients:

• “you have the right to an open and transparent relationship with the organisation providing your care. You must be told about any safety incident relating to your care which in the opinion of a healthcare professional, has caused or could still cause significant harm or death. You must be given the facts, an apology, and any reasonable support you need”

Staff:

• “you should aim to be open with patients… if anything goes wrong; welcoming and listening to feedback and addressing concerns promptly and in the spirit of cooperation.”

If you want to get in touch at:

• safetyandlearningenquiries@resolution.nhs.uk

Published June 2017, at NHS resolution (opens in new window).

11.3 Appendix C Duty of candour criteria and requirements

In order to meet this duty the trust must:

• act in an open and transparent way with relevant persons in relation to care and treatment provided to people who use our services in carrying on a regulated activity
• tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable patient safety incident (PSI) has occurred and provide support to them in relation to the incident, including when giving the notification
• provide an account of the incident, which to the best of its knowledge is true, of all the facts that it knows about the incident as at the date of notification
• advise the relevant person what further enquiries it believes are appropriate
• offer an apology
• follow this up by giving the same information in writing and providing an update on the enquiries
• keep a written record of all communication with the relevant person.
• the CQC will monitor compliance with the key requirements with respect to the duty of candour
• there should be a board-level commitment to being open and transparent in relation to care and treatment
• candour, openness and honesty should be encouraged at all levels, as an integral part of a culture of safety that supports organisational and personal learning
• providers should take action to tackle bullying, harassment and undermining, and must investigate any instances where a member of staff may have obstructed another in exercising their duty of candour
• staff should receive appropriate training, and there should be arrangements in place to support staff who are involved in a notifiable patient safety incident
• there is no formal deadline under the regulation for notifying the relevant person of an incident, but the guidance refers to the NHS standard contract provision which requires notification within ten working days of the incident being reported and sooner where possible
• where the degree of harm is not yet clear but may fall within the criteria in the regulation (death, severe harm, moderate harm or prolonged psychological harm) the relevant person must still be informed of the incident in line with the regulations
• although there is a requirement to investigate incidents which ‘could result in’ harm as described above, the CQC state that there is no need to inform a person under the regulation when a ‘near miss’ has occurred, resulting in no harm to that person
• where the incident relates to care delivered by another provider, RDaSH would work with others, and that provider would then be responsible for notifying the relevant person of the incident
• there is guidance as to what constitutes ‘reasonable support’, for example, third party emotional or advocacy support, arranging further treatment, where necessary by a different team or provider, and providing support to access RDaSH complaints procedure
• where, despite reasonable attempts, the relevant person cannot be contacted, or does not wish to communicate with the provider (including historic incidents) a written record should be kept of the attempts to contact or speak with them

11.4 Appendix D Duty of candour step by step

1. Provide initial verbal apology and explanation of what happened as far as is known at that time.
2. Complete Ulysses IR1 and record the conversation in the relevant section of the form.
3. Inform manager as soon as practicable.
4. Offer patient or relevant person support during and after the process, including, but not limited to, interpreters, advocates, counselling, self-help groups, transfer of care to another team, and so on.

11.4.1 Within 10 working days the manager must

• Nominate a Lead to comply with the duty of candour.
• Notify patient that incident has occurred, this must be:
  • in person (if possible)
  • include an apology, what happened and what is going to happen next, investigation
  • be delivered by a suitable manager from the service involved
  • be followed by written notification
  • be recorded in the duty of candour section of the Ulysses IR1 form
• Carry out an investigation and provide an explanation of the events and circumstances which resulted in the incident.
• Provide and maintain written records of the interactions with the patient or relevant person.
• Provide a copy of the investigation report to the patient or relevant person, this report has to be approved for release and suitably redacted if required.
• Offer patient or relevant person support after the process, including, but not exclusively, counselling, self-help groups, transfer of care to another team, and so on. Also the your opinion counts and complaints process.

11.5 Appendix E Process flow chart

1. Patient safety incident occurs.
2. Being open at the time of the Incident.
3. Ensure the safety of those involved and the area, assist as required.
4. Provide verbal apology and explanation of what happened as far as is known at that time.
5. Advise and, if possible, agree with the patient what further enquiries are appropriate.
6. Complete IR1 and record the conversation in the relevant section of the form.
7. Provide reasonable support to the patient or service user, their families, or carers.
8. Was the severity of harm moderate, major, catastrophic or death? or psychological harm over 28 days?
9. No, duty of candour does not apply, but being open initiative applies to all patient safety incidents.
10. Yes, Within 10 working days the allocated manager must Notify patient that incident has occurred. This must be:
    • delivered by a suitable manager from the service involved
    • in person
    • include all known facts about the incident
    • include a repeat apology
    • include next steps
    • be followed by written notification
    • be recorded in the duty of candour section of the Ulysses IR1
    • commence an investigation into the incident
11. Within 60 working days (If the incident is being investigated as an SI, or an external investigation, then the 60 day limit may be exceeded) of the incident the manager must:
    • carry out an investigation to provide an explanation of the events and circumstances which resulted in the incident
    • keep the patient or relevant person informed of progress during the investigation
    • provide and maintain written records of the interactions with the patient or relevant person
    • provide an explanation and offer a copy of the investigation report to the patient or relevant person, this report has to be approved for release and suitably redacted if required
    • offer patient or relevant person support during and after the process, including, but not exclusively, counselling, self-help groups, transfer of care to another team, and so on. Also the your opinion counts and complaints process, incident is now complete

11.6 Appendix F Actual harm grading scale

11.6.1 Actual harm grading scale

11.6.1.1 No harm (1)

• Incident prevented, any patient safety incident that had the potential to cause harm but was prevented, and no harm was caused to patients receiving NHS-funded care.
• Incident not prevented, any patient safety incident that occurred but no harm was caused to patients receiving NHS-funded care.
• Minimal injury requiring no or minimal intervention or treatment.
• No time off work.

11.6.1.2 Minor (2)

• Minor injury or illness, requiring minor intervention.
• Minor treatment is defined as first aid, additional therapy, or additional medication.
• Increase in length of hospital stay by 1 to 3 days.
• Requiring time off work for greater than 3 days.

11.6.1.3 Moderate (3)

• Injury requiring a return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another area such as intensive care as a result of the incident.
• Semi-permanent injury taking up to 12 months to recover.
• Increase in length of hospital stay by 4 to 15 days.
• RIDDOR reportable incident.
• Requiring time off work for 4 to 14 days.

11.6.1.4 Major (4)

• Major injury leading to long-term incapacity or disability.
• Increase in length of hospital stay by greater than 15 days.
• Requiring time off work for greater than 14 days.

11.6.1.5 Catastrophic (5)

• Permanent harm directly related to the incident and not related to the natural course of the patient’s illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ, or brain damage.
• Multiple permanent injuries or irreversible health effects.

11.6.1.6 Death (6)

• The death must be related to the incident rather than to the natural course of the patient’s illness or underlying condition.
• Death as a result of an incident classified as a ‘never event’.

11.6.2 Specific harm grading scale

11.6.2.1 Minor (2)

Pressure ulcers:

• patient develops trust acquired pressure ulcer category 1 or 2 or a moisture lesion

Falls:

• fall causing harm that resolves within one month, for example, scalp laceration

Medication errors:

• medication error resulting in patient harm which resolves within 1 month, for example, increased dose of antihypertensive administered in error which requires additional BP monitoring

11.6.2.2 Moderate (3)

Pressure ulcers:

• trust acquired category 3 or 4 pressure ulcer, multiple trust acquired category 2 pressure ulcers causing significant affects judged to be moderate

Falls:

• fall causing harm that takes 1 to 12 months to resolve, for example, fractured humerus, seriousness of the incident or affects is judged to be moderate

Medication errors:

• medication error resulting in patient harm that takes 1 to 12 months to resolve seriousness of the incident or affects is judged to be moderate

11.6.2.3 Major (4)

Pressure ulcers:

• multiple trust acquired category 3 or 4 pressure ulcer

Falls:

• as moderate, but judged to be a major harm

Medication errors:

• as moderate, but judges to be a major harm

11.6.2.4 Catastrophic (5)

Pressure ulcers:

• pressure ulcer resulting in sepsis and sepsis recorded on death certificate

Falls:

• fall causing an injury which contributes to patient death, for example, recorded on part 2 of death certificate or causes permanent harm or permanent disability, for example, fractured neck of femur

Medication errors:

• medication error which contributes to patient death, for example, failure to reconcile cardiac medication contributing to patient death

11.6.2.5 Death (6)

Falls:

• fall leading to injury that directly causes death of patient

Medication errors:

• medication incident directly resulting in patient death, for example, medication administered to which the patient had a known allergy and administration results in death

11.7 Appendix G Letter template

• Appendix G Letter template

11.7 Appendix H Report template

• Appendix H Report template

11.8 Appendix I Report cover letter

• Appendix I Report cover letter

11.9 Appendix J Monitoring and management process

Day numbers refer to days after the incident is reported.

1. Incident is reported.
2. System emails manager, HPS, and medical devices and projects officer (MDPO).
3. Manager moderates the incident report.
4. DOC incident added to DOC monitoring spreadsheet (MDPO). Exceptions to be raised with head of patient safety (HPS).
5. If DOC section on Ulysses IR1 is not commenced, notification email to be sent to DOC lead or manager to inform that it is a DOC and what is required (MDPO).
6. Day 10 incident marked as RED on spreadsheet if no contact or letter. Telephone to remind manager or DOC lead if no contact and, or letter recorded on Ulysses IR1 (MDPO). Reason for delay is recorded. If still not completed, this would be escalated to care group director (MDPO or HPS) in their monthly report.
   • SI (or external report), SI report due date entered onto Ulysses IR1 as target date for report (MDPO). Once known, SI investigator is entered on Ulysses IR1 as DOC lead for the incident (MDPO). Weekly check of live SI cases to confirm progress of report (MDPO). Once SI report completed and reviewed by CCG, email SI investigator to chase up final feedback to patient or family. (MDPO) If report is not forthcoming escalate to HPS (MDPO). Escalate to HPS, care group director, or director of nursing and quality in monthly report.
   • Not SI, Structured review or RCA day 60 email DOC lead to remind about report (MDPO). Chase on a weekly basis (MDPO). Escalate to HPS, care group director, or director of nursing and AHPS n monthly report (MDPO).

Assistance and advice can be called for at any time in this process from the head of patient safety (HPS) or medical devices and project officer (MDPO).

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Document control

• Version: 8.1.
• Unique reference number: 319.
• Ratified by: Corporate policy approval group.
• Date ratified: 29 January 2024.
• Name of originator or author: Head of patient safety.
• Name of responsible individual: Executive director of nursing and allied health professions.
• Date issued: 1 February 2024.
• Review date: May 2025.
• Target audience: All RDaSH staff with roles in patient care.

Page last reviewed: April 15, 2024
Next review due: April 15, 2025

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